NCT04453930

A Study of Sequential Therapy of Camrelizumab Combined With Chemotherapy（Irinotecan Plus Platinum）and With Apatinib in Participants With Untreated Advanced Small Cell Lung Cancer（SCLC）

A Single-arm，Open Lable Study of Sequential Therapy of Camrelizumab Combined With Chemotherapy（Irinotecan Plus Platinum）and With Apatinib in Participants With Untreated Advanced Small Cell Lung Cancer（SCLC）

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single arm, open label, single center, prospective study was designed to evaluate the safety and efficacy of Sequential Therapy of Camrelizumab (humanized monoclonal antibody against Programmed death 1 \[PD-1\] ) in combination with Chemotherapy（Irinotecan plus Platinum）and with Apatinib (selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor \[TKI\]) in chemotherapy-naive participants with SCLC. Participants will receive Camrelizumab + Irinotecan + Platinum on 21-day cycles for 4-6 cycles in the induction phase followed by maintenance with Camrelizumab + Apatinib until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab，an engineered anti-PD-1 antibody	Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/5/6) and maintenance phase (Cycle onward).
DRUG	Platinum	Carboplatin： Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/5/6). Cisplatin： Cisplatin intravenous infusion was administered at a dose of 30 milligrams per square meter (mg/m\^2) on Day 1，8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6).
DRUG	Irinotecan	Irinotecan intravenous infusion was administered at a dose of 65 milligrams per square meter (mg/m\^2) on Day 1，8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6).
DRUG	Apatinib	Apatinib was administered at a dose of 250 mg during the maintenance phase.

Timeline

• Start date: 2020-06-08
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2020-07-01
• Last updated: 2020-07-01

Locations

1 site across 1 country: China